Event assessment tab—user actions
User Action | Result |
---|---|
Click Datasheet column's icon |
The system does the following:
|
Click Product Name link |
Displays the name for the selected product. |
Click Event Description link |
Displays the Event Information for the selected event. |
Click Datasheet Description link |
Displays the active on date, revision number, and first 1000 terms in the datasheet. Click Print to view all the terms and click Export to export all the labeled terms to an Excel file in a single column with column header as Labeled Terms. |
Event assessment—field descriptions
Field or Control Name | Description |
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Recalculate |
Refreshes the Event Assessment section with the newly entered data if new suspect products or events are entered, or the Event Relationship is modified. |
Product |
Populated when events are entered in the Products tab and appears as:
|
Causality as Reported/Source/ Method/ Result |
Provides the source of causality as reported such as Investigator, Healthcare Professional, and so on. Provides the method used for causality determination. Provides the result of the causality assessment. |
Causality as Determined/Source/ Method/ Result |
Provides the source of causality as determined such as Sponsor, MAH, and so on. Provides the method used for causality determination. Provides the result of the causality assessment. |
Other Causality /Source/ Method/ Result |
Provides the source of causality from any additional source such as NCA. Provides the method used for causality determination. Provides the result of the causality assessment. |
Event |
Populated when events are encoded and appears as:
|
D/S |
Displays the Diagnosis/Symptom details by D or S. |
Seriousness Severity Duration |
Displays the seriousness, severity, and the duration of the event. |
Listedness |
Indicates whether the system found the event on the datasheet for this product. This field is enabled for company products and non-company study drugs. |
Parent topic: Enter event assessment information